Gaviscon duo tab o smaku ovocuv leshnih

Package Leaflet: Information for the Patient

Gaviscon Duo Tab Fruit Flavor

250 mg + 106.5 mg + 187.5 mg, Chewable Tablets

Sodium Alginate + Sodium Hydrogen Carbonate + Calcium Carbonate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

Always take this medicine exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet:

• 1. What is Gaviscon Duo Tab Fruit Flavor and what is it used for
• 2. Important information before taking Gaviscon Duo Tab Fruit Flavor
• 3. How to take Gaviscon Duo Tab Fruit Flavor
• 4. Possible side effects
• 5. How to store Gaviscon Duo Tab Fruit Flavor
• 6. Contents of the package and other information

1. What is Gaviscon Duo Tab Fruit Flavor and what is it used for

Gaviscon Duo Tab Fruit Flavor is a combination of alginate and two acid-neutralizing agents (calcium carbonate and sodium hydrogen carbonate), which work in two ways:

• 1. Creating a protective barrier over the stomach contents, allowing for the relief of heartburn (the soothing effect may last up to 4 hours).
• 2. Neutralizing excess stomach acid to relieve pain and discomfort.

This medicine is used to treat symptoms of acid reflux, such as heartburn, acid regurgitation, and indigestion, for example after meals or during pregnancy.

2. Important information before taking Gaviscon Duo Tab Fruit Flavor

When not to take this medicine

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Gaviscon Duo Tab Fruit Flavor, discuss with your doctor or pharmacist:

• if you have or have had serious kidney or heart disease, as some salts may affect these diseases (you should discuss the salt content of the medicine with your doctor).
• if you have previously been diagnosed with intolerance to some sugars.
• if you have severe kidney problems.
• if you have electrolyte disturbances causing low phosphate levelsin the blood (hypophosphatemia).
• If you have reduced stomach acid, the medicine may be less effective.

As with other antacids, taking this medicine may mask the symptoms of other, more serious conditions.

If symptoms persist for more than 7 days, consult your doctor.

Children

Do not give this medicine to children under 12 years of age. There is a risk of increased sodium levels in the blood (hypernatremia) in children with kidney problems or stomach and intestinal inflammation.

Gaviscon Duo Tab Fruit Flavor and other medicines

Do not take this medicine within 2 hours of taking other oral medicines, as it may interfere with their action. This is especially important if you are taking antihistamines, antibiotics (tetracyclines and quinolones, such as norfloxacin), iron preparations, thyroid hormones, antifungal agents (such as ketoconazole), digoxin, and beta-adrenolytics (used in heart disease), neuroleptics (used in mental illness), thyroxine, chloroquine (used in malaria), bisphosphonates (used in osteoporosis), and estramustine (used in prostate cancer). You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

You can take this medicine if you are pregnant, breastfeeding, or planning to have a baby. As with all medicines, the duration of treatment should be as short as possible.

Important information about some ingredients of this medicine

This medicine contains 5.86 mg of aspartame (E951) in each chewable tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder in which phenylalanine accumulates because the body cannot remove it properly. The chewable tablets contain azorubine (E122), which may cause an allergic reaction. The medicine contains 223.7 mg (9.728 mmol) of sodium per dose of four chewable tablets. The maximum recommended daily dose of this medicine contains 895 mg of sodium (found in salt). This corresponds to 44.75% of the recommended maximum daily sodium intake for an adult. If you take this medicine every day for a long time, you should talk to your pharmacist or doctor, especially if you have been advised to follow a low-sodium diet. The medicine contains 300 mg (7.5 mmol) of calcium per dose of four chewable tablets. Before taking this medicine, you should talk to your doctor if you have kidney stones or high calcium levels in the blood. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Gaviscon Duo Tab Fruit Flavor

Always take this medicine exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. Oral administration. Chew thoroughly before swallowing. Adults and children over 12 years:Take 2 to 4 chewable tablets after meals and before bedtime, up to 4 times a day. Children under 12 years:Not recommended for children under 12 years of age.

Overdose of this medicine

It is unlikely that taking too much of this medicine will harm you. However, you may experience bloating and abdominal discomfort. If symptoms persist, consult your doctor. Missed dose:Do not take a double dose to make up for a missed dose. Continue taking the medicine as before.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience side effects, stop taking the medicine and consult your doctor immediately. Very rarely (may affect up to 1 in 10,000 people), an allergic reaction to the ingredients of the medicine may occur. Symptoms may include abdominal pain, diarrhea, nausea, vomiting, rash, itching, dizziness, swelling of the face, lips, tongue, or throat, and difficulty breathing. Consuming large amounts of calcium carbonate, an ingredient of this medicine, may cause elevated blood pH (alkalosis), high calcium levels in the blood (hypercalcemia), increased stomach acid production, and constipation. These usually occur after taking higher than recommended doses.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gaviscon Duo Tab Fruit Flavor

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month. Do not store above 30°C. Store in the original package to protect from moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Gaviscon Duo Tab Fruit Flavor contains

The active substances in each chewable tablet are 250 mg of sodium alginate, 106.5 mg of sodium hydrogen carbonate, and 187.5 mg of calcium carbonate. The other ingredients are: macrogol 20, mannitol type 100, copovidone, blueberry flavor (flavoring substances, arabic gum, potato maltodextrin, sucrose, glycerol triacetate), raspberry flavor (flavoring substances, corn starch, propylene glycol, modified corn starch), fruit flavor (flavoring substances, arabic gum, potato maltodextrin, sucrose, glycerol triacetate, propylene glycol), acesulfame potassium, aspartame (E951), azorubine, aluminum lake (E122), magnesium stearate, xylitol.

What Gaviscon Duo Tab Fruit Flavor looks like and contents of the package

Flat, round, two-layer chewable tablets with a fruit flavor. One layer of the chewable tablet is pink and has a slightly speckled appearance with GDB markings on the surface, and the other layer is white with sword and circle markings. This medicine is available in packages containing 12, 16, 24, 32, 48, 60 chewable tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Reckitt Benckiser (Poland) S.A., ul. Okunin 1, 05 – 100 Nowy Dwór Mazowiecki, tel. 0 801 88 88 07

Manufacturer/Importer:

RB NL Brands B.V., Schiphol Boulevard 207, 1118 BH Schiphol, Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet: